Cleared Traditional

K041503 - HOVERJACK AIR PATIENT LIFT DEVICE (FDA 510(k) Clearance)

Aug 2004
Decision
66d
Days
Class 2
Risk

K041503 is an FDA 510(k) clearance for the HOVERJACK AIR PATIENT LIFT DEVICE. This device is classified as a Lift, Patient, Ac-powered (Class II - Special Controls, product code FNG).

Submitted by D.T. Davis Enterprises , Ltd. (Bethlehem, US). The FDA issued a Cleared decision on August 12, 2004, 66 days after receiving the submission on June 7, 2004.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5500.

Submission Details

510(k) Number K041503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date August 12, 2004
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FNG — Lift, Patient, Ac-powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5500